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Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301808
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : May 13, 2014
Last Update Posted : December 14, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Cisplatin Drug: Docetaxel Drug: Pemetrexed disodium Radiation: Radiation therapy Phase 2

Detailed Description:



  • Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel.


  • Assess the progression-free survival and overall survival.
  • Assess the toxicity of this regimen.

OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.

After completion of study therapy, patients are followed at 1 month and periodically thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)
Study Start Date : November 2005
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Drug: Cisplatin
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Other Names:
  • Platin
  • Cisplatinum

Drug: Docetaxel
Docetaxel 75 mg/m2 on day 1 of each cycle
Other Name: Taxotere®

Drug: Pemetrexed disodium
Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Other Name: Alimta

Radiation: Radiation therapy
Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.

Primary Outcome Measures :
  1. Probability of Overall Survival at One Year [ Time Frame: at 1 year ]
    Overall Survival at one year using Kaplan-Meier product-limit analysis

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later. ]
    Progression-free survival using Kaplan-Meier estimates

  2. Overall Survival [ Time Frame: Date of registration to the date of death ]
    Overall survival using Kaplan-Meier estimates

  3. Toxicity [ Time Frame: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year ]
    Toxicity: total number of SAEs and other AEs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:

    • Stage IIIA disease, meeting all of the following criteria:

      • Mediastinal lymph node involvement

        • Greater than one mediastinal lymph node enlarged on CT scan, confirmed by positron emission tomography (PET) scan
      • Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan
    • Stage IIIB disease, meeting all of the following criteria:

      • N3 lymph node involvement

        • Enlarged N3 lymph nodes on CT scan confirmed by PET scan

          • Lymph node involvement may not extend to cervical lymph nodes other than supraclavicular lymph nodes
      • Right-sided primary tumor with left vocal cord paralysis
      • Evidence of tumor extension into the mediastinum and/or mediastinal structures by mediastinoscopy, bronchoscopy, or CT scan
      • No evidence of malignant pleural effusion unless effusion is only evident on CT scan
      • No more than 1 parenchymal lesions on the same or opposite sides of the lung
  • No brain metastases by CT scan or MRI


  • SWOG performance status 0 or 1
  • Platelet count ≥ 100,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 45 mL/min
  • Bilirubin normal
  • Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving greater than 20 Gy of radiation ≤ 40%
  • FEV_1 ≥ 70% of predicted
  • DLCO ≥ 50 mL/min
  • No other concurrent malignancy

    • Prior malignancy allowed provided it is in clinical control and is not likely to impact clinical outcome in the opinion of the treating physician
  • No peripheral neuropathy ≥ grade 2
  • No serious medical illness, including, but not limited to, any of the following:

    • Uncontrolled congestive heart failure
    • Uncontrolled angina
    • Myocardial infarction
    • Cerebrovascular event within the past 6 months
    • History of chronic active hepatitis
    • History of HIV infection
    • Active bacterial infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or dexamethasone


  • No prior chemotherapy or radiotherapy for NSCLC
  • No concurrent participation in another therapeutic investigational study
  • Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium administration provided the patient has normal renal function
  • No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days before, during, and for 2 days after pemetrexed disodium administration

    • Patients on long-acting NSAIDs (e.g. naproxen sodium, diflunisal, nabumetone, or celecoxib) must be willing or able to discontinue usage 5 days prior to, during, and for 2 days after pemetrexed disodium administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301808

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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shirish M. Gadgeel, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT00301808    
Other Study ID Numbers: CDR0000461591
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-D-2934 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
WSU-0507002542 ( Other Identifier: Wayne State University - Human Investigation Committee )
First Posted: March 13, 2006    Key Record Dates
Results First Posted: May 13, 2014
Last Update Posted: December 14, 2017
Last Verified: July 2014
Keywords provided by Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors